Duns Number:715919973
Device Description: Endotracheal Tubes are intended for oral intubation and are indicated for use in airway ma Endotracheal Tubes are intended for oral intubation and are indicated for use in airway management and other suitable medical application.
Catalog Number
1200831
Brand Name
ENDOTRACHEAL TUBE, WIRE REINFORCED, WITH CUFF
Version/Model Number
I.D. 7.5MM (FR.31), 400MM LONG TYPE
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BTR
Product Code Name
Tube, Tracheal (W/Wo Connector)
Public Device Record Key
60c91a9c-131e-4d7e-bf3e-016f296ce88d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |